Liofilchem S. R. L.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
34
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLOctober 2, 2025
K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)August 20, 2025
K243202MTS Ceftobiprole 0.002-32 µg/mLJanuary 30, 2025
K230479ComASP Cefiderocol 0.008-128May 18, 2023
K211672MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mLOctober 20, 2021
K200180MTS Omadacycline 0.002 - 32 ug/mLMarch 20, 2020
K192345MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mLOctober 31, 2019
K191908MTS Imipenem 0.016-256 µg/mLSeptember 4, 2019
K191809MTS Imipenem-relebactam 0.002/4-32/4 µg/mLAugust 23, 2019
K190914MTS Doxycycline 0.016 - 256 µg/mLMay 29, 2019
K190252MTS Gentamicin 0.016 - 256 µg/mLMarch 22, 2019
K183527MTS Ciprofloxacin 0.002 - 32 µg/mLMarch 19, 2019
K183140MTS Tetracycline 0.016 - 256 ug/mLJanuary 11, 2019
K183115MTS Levofloxacin 0.002 - 32 µg/mLDecember 20, 2018
K182922MTS Omadacycline 0.002-32 µg/mLDecember 14, 2018
K182557MTS Eravacycline 0.002 - 32 µg/mLNovember 2, 2018
K181889MTS Penicillin 0.002- 32 µg/mLSeptember 13, 2018
K181708MTS Plazomicin 0.016-256 µg/mLJuly 31, 2018
K180886Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mLMay 18, 2018
K180339Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mLApril 4, 2018